The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

Device Description

The Laport® Trocars are for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. The Laport® Trocars are consisting of a sleeve and needle in sizes ranging from 5 to 12 mm in diameter. There are three different needles: Safety, Optical and Bladeless Type. The Safety Type has a sharp flat-bladed tip and shield. The shield on the Safety Type needle is designed to cover the flat-bladed tip to protect internal structures from puncture once the abdominal or thoracic cavity has been entered. The Optical Type has a transparent tip for use with an endoscope to provide visualization for insertions. The Bladeless Type has a plastic tip which reduces hazards during puncture of abdominal cavity.

AI/ML Overview

This document is a 510(k) summary for the Laport® Trocars. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in a quantitative, statistical manner typically seen for complex AI/ML medical devices. Therefore, much of the requested information regarding statistical studies, expert adjudication, and sample sizes for training/test sets is not available in this document.

However, I can extract the information that is present and highlight the type of testing performed.

Type of Device: Surgical Trocar (not an AI/ML device)

Given that this is a 510(k) submission for a surgical trocar, physical and chemical performance tests are presented, not diagnostic or AI-driven performance metrics. Therefore, many of the questions related to AI/ML device testing (e.g., MRMC studies, ground truth establishment for AI, training set size) are not applicable or detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

For a surgical trocar, acceptance criteria are generally qualitative or based on passing specific physical, chemical, and biological tests. The document describes the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices," implying successful completion of these tests. Specific numerical acceptance criteria or performance values are not provided in this summary.

Test Type	Test Method	Reported Performance / Conclusion
Sterilization Validation	ISO 11737-1	Met standard, supports substantial equivalence.
Shelf Life Validation	Not specified (implied to meet requirements)	Met requirements, supports substantial equivalence.
Biocompatibility: Cytotoxicity	ISO 10993-5	Met standard, supports substantial equivalence.
Biocompatibility: EO Sterilization Residuals	ISO 10993-7	Met standard, supports substantial equivalence.
Biocompatibility: Skin Sensitization	ISO 10993-10	Met standard, supports substantial equivalence.
Biocompatibility: Systemic Toxicity	ISO 10993-11	Met standard, supports substantial equivalence.
Biocompatibility: Irritation	ISO 10993-10	Met standard, supports substantial equivalence.
Performance: Appearance	Visual Inspection	Met visual requirements.
Performance: Measurement	Inspecting dimensions using vernier calipers	Met dimensional requirements.
Performance: Leakage	When the sample was put air in trocar sleeve with air pressure after close the valve, it should not be leaked. (Bubble test for Intraperitoneal Pressure Test)	No leakage detected.
Performance: Extraction Test	Appearance, pH, KMnO4, Evaporating residue, Heavy Metal, UV-vis Spectrum (This seems to describe tests on extractables, not mechanical extraction of the device.)	Met requirements.
Non-Clinical (Animal) Test: Trocar Insertion & Extraction	The operator (expert veterinarian) scored the experience when the trocar was inserted into the abdominal cavity of animals and extracted according to pre-set scoring index. Insertion, Fixation, and Extraction were evaluated.	Good performance, comparable to predicates.
Non-Clinical (Animal) Test: Intraperitoneal Pressure	The time for intraperitoneal pressure to reach a certain mmHg was recorded. And the bubble test was performed to check the leakage of gas. Time to insufflation was evaluated. The text states "bubble test was performed to check the leakage of gas," which relates to the previous leakage test of the device itself. The time to reach certain mmHg and insufflation time seem to relate to the system as a whole with the trocar.	Acceptable pressure maintenance and insufflation time.
Non-Clinical (Animal) Test: Convenience of performing laparoscope	The operator inserted the laparoscope through the trocar needle of optical test devices and scored the convenience of performing laparoscope according to the scoring index demonstrated below. Visualization was also evaluated.	Convenient, good visualization.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not explicitly stated in the document for any of the performance tests. For animal testing, it mentions "micropigs" but not the number of animals used.
Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study is described as "Non-Clinical(Animal) test using micropigs," implying a prospective animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For the non-clinical (animal) tests, it states "The operator (expert veterinarian) scored the experience." This indicates at least one expert, but the exact number and detailed qualifications (e.g., years of experience) are not provided beyond "expert veterinarian." This is not a "ground truth" establishment in the sense of clinical disease diagnosis, but rather an expert evaluation of device performance.

4. Adjudication method for the test set

Not applicable/Not described. The expert veterinarian "scored the experience," suggesting a single evaluation per test, not a consensus or adjudication process involving multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No. This type of study is relevant for diagnostic devices (especially AI/ML image analysis) where human reader performance is being evaluated or compared. It is not applicable for a surgical trocar.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, outcomes data) is not relevant for this device. For the performance tests, the "truth" is determined by meeting engineering specifications, ISO standards, and the assessment by an expert veterinarian for handling characteristics in an animal model.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary specific to the provided document:

The provided document describes a 510(k) submission for a surgical trocar (Laport®). The "acceptance criteria" discussed are primarily compliance with ISO standards for sterilization, biocompatibility, and various physical and mechanical performance tests (e.g., appearance, measurement, leakage, extraction). A non-clinical animal test was also conducted, where an "expert veterinarian" evaluated the device's insertion, fixation, extraction, intraperitoneal pressure management, and convenience for laparoscope use.

The document states that all tests demonstrated that the device is "substantially equivalent to the predicate devices." However, it does not provide quantitative performance metrics, specific numerical acceptance thresholds, or statistical analysis of the test results. The sample sizes for these tests are also not specified in this summary. This is typical for 510(k) summaries for such devices, where the focus is on demonstrating equivalence through a battery of standard tests rather than detailed statistical clinical trials, especially if it's not a novel technology or an AI/ML device.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is centered on the page.

August 29, 2017

Sejong Medical Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc 690 Roosevelt Irvine, California 92620

Re: K171741

Trade/Device Name: Laport Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 5, 2017 Received: June 12, 2017

Dear Ms. Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171741

Device Name

Laport ®

Indications for Use (Describe)

The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

(K171741)

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date:

1. Submitter/Applicant

Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, Gyeonggi-do Republic of Korea 10880

Tel: +82-31-945-8191 Fax: +82-31-945-8190

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: Laport ®
Common Name: Sterile Trocars for Endoscopic surgery ●
Classification: Class II ●
Classification regulation: 21 CFR 876.1500 ●
. Product Code: GCJ

Predicate Devices: 4.

Primary Predicate Device: ENDOPATH® III Trocars (K032676) by Ethicon Edo-Surgery, Inc. Reference Predicate Deice: LAPORT (K092584) by MGB EndoskopischeGerate GmbH Berlin

510(k) Submission.

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5. Description:

6. Indication for use:

The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instr uments.

Performance Data 7.

The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.

· Sterilization Validation Test in accordance with ISO11737-1
· Shelf Life Validation Test
· Biocompatibility Tests in accordance with ISO 10993

Cytotoxicity	ISO 10993-5
Ethylene Oxide SterilizationResiduals	ISO 10993-7
Skin Sensitization	ISO 10993-10
Systemic Toxicity	ISO 10993-11
Irritation	ISO 10993-10

· Performance Tests: Appearance, Measurement, Leakage, and Extraction, and Non-Clinical(Animal) test

Test	Test Method
Appearance	Visual Inspection
Measurement	Inspecting dimensions using vernier calipers
Leakage	When the sample was put air in trocar sleevewith air pressure after close the valve, itshould not be leaked.
Extraction Test	Appearance, pH, KMnO4, Evaporating

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Non-Clinical(Animal)test using micropigs	residue, Heavy Metal, UV-vis Spectrum
	Trocar Insertion & Extraction Test:The operator (expert veterinarian) scored theexperience when the trocar was inserted intothe abdominal cavity of animals andextracted according to pre-set scoring index.Insertion, Fixation, and Extraction wereevaluated.
	Intraperitoneal Pressure Test:The time for intraperitoneal pressure to reacha certain mmHg was recorded. And thebubble test was performed to check theleakage of gas. Time to insufflation wasevaluated.
	Convenience of performing laparoscope:The operator inserted the laparoscopethought the trocar needle of optical testdevices and scored the convenience ofperforming laparoscope according to thescoring index demonstrated below.Visualization was also evaluated.

All the test results demonstrated that the subject device is substantially equivalent to the predicate devices.

8. Basis for Substantial Equivalence

The subject device, Laport® incorporates the same intended use with the predicate devices. The subject device is composed of similar materials with the predicate devices. All the devices are similar in physical & mechanical properties. The differences between the subject device and the predicate device are universal seal and lip valve part. The subject device, Laport® has a universal seal that facilitate using a wide range of instruments from 5mm to 12mm.

We have performed the various performance tests, and the test results support that the subject device is substantially equivalent to the predicate devices.

9. Conclusion

Upon reviewing the information including testing data provided in this submission and comparing intended use, principle of operation and overall technological characteristics, we conclude that the Laport® is substantially equivalent to the predicate devices.

510(k) Submission.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.